During surgical procedures in an operating room of a hospital, nearly always there are surgical sponges used, whereby blood which comes as a consequence of bleeding caused during the surgical procedure is captured by the surgical sponges. The sponges are discarded, usually by being placed into a kick bucket, and thereafter they are counted and disposed of.
A constant risk during surgical procedures is that there may be a mis-count, whereby the risk that a surgical sponge may accidentally be left in a wound or opening caused by the surgical procedure, greatly increases. Morevoer, it is the duty of the operating room personnel to determine if there is excessive loss of blood by the patient, during the surgical procedure.
Thus, most operating rooms have very strict sponge count requirements, whereby the number of sponges in the operating room is counted before the surgical procedure, a count is maintained and updated during the surgical procedure, and a final count is made before termination of the surgery and closing of the wound or opening. The continuing count of soiled sponges is generally the responsibility of one, non-sterile, nurse in the operating room, who may not enter the sterile area, and among whose responsibilities are included that of sorting and counting the surgical sponges.
Moreover, there is a further responsibility of the nursing and anesthesiology persons assisting at the surgical procedure to determine whether there is excessive blood loss by the patient. For those reasons, it is convenient that the soiled surgical sponges should be maintained in one general place, so that skilled surgical personnel may, by visual inspection, determine whether there may have been excessive blood loss or not. However, it is often desirable that there should be a more accurate method by which blood loss may be determined, and that is to weigh the soiled surgical sponges and to deduct from the result the weight of the sponges when unused (either dry or with saline solution substantially wrung out therefrom), whereby quite accurate determination of blood loss may be made.
Still further, it is a general concern in operating rooms that contamination should be maintained at the lowest possible level, so that the risk of post-operative infection may be substantially precluded. Thus, it is desirable that as much as possible the soiled surgical sponges should be contained and preferably covered.
In most cases, at least small surgical sponges (about 10 cm. square) are disposed of after use--i.e., they are only used once. However, larger surgical sponges such as laparotomy sponges may, in some hospitals, be recovered following the surgical procedure for washing and re-use. In any event, however, the correct count of all such sponges used in a surgical procedure must be determined, either before the sponges are disposed of or returned to laundry and sanitizing procedures for re-use.
A number of procedures have been used in the past, for counting and maintaining the count of surgical sponges being used. Such procedures have included laying the sponges on the floor of the operating room--usually on a folded towel--or the use of certain commercially available products. However, none of the procedures used, to date, have adequately provided for an accurate weighing of the soiled surgical sponges for determination of blood loss, while at the same time providing ease of access to the soiled sponges, ease of access to the storage for the soiled sponges, and ease of count and re-count.
For example, an article about blood loss determination in the Journal of the Association of Operating Room Nurses, (AORN) for June 1981, volume 33, No. 7, by Darden, at pages 1368 to 1380 discusses ways by which blood loss may be determined by inspection of soiled surgical sponges. That article points out that blood loss may range from moderate to severe, and notes particularly that small amounts of blood loss in infants and children may result in critical conditions for the patient. Moreover, the article suggests that sponge tallies and weighing of the sponges should be made at least every 15 minutes, otherwise the determination of blood loss may be quite inaccurate because of the drying blood in the sponges.
However, although the article suggests that sponges should be placed conveniently for the anesthesiologist--who has the responsibility for determining blood loss--to see, and suggests that scales used to measure the weight of soiled surgical sponges should be protected from fluid accumulation, none of the procedures discussed lead to any apparatus by which a count may be easily made, details of the count entered, or blood loss determined, with a minimum of handling of the sponges, and using simple and very inexpensive equipment and disposable apparatus.
Other prior art, however, discloses proposals for handling surgical sponges, and certain kinds of apparatus which are available in the market.
For example, Dorton, in U.S. Pat. No. 3,749,237, issued July 31, 1973, teaches a bag strip for handling soiled surgical sponges, whereby a plurality of strips is formed on a roll of thermoplastic material, which strips are separated from the roll one at a time. Each strip is adapted to be hung from one of its ends, from any suitable support such as an intravenous pole, and a plurality of pouches is formed in the strip one under another. The pouches may either be small or large, the strip being formed with a central, easily rupturable, longitudinal seam from top to bottom, whereby small or large sponges may be accommodated and a sponge count made by inspection. The patent assumes that, especially when the strip is hung from an intravenous pole, a scale may also be provided.
However, use of the Dorton apparatus in an operating room requires that each of the soiled surgical sponges be removed from the kick bucket or elsewhere, and lifted up to the level of the opening of the next respective pouch into which that soiled sponge will be placed. That opening may be 10 or 20 cm. above the level of the top of the kick bucket, or it may be 100 or more cm. above the top of the kick bucket, because the pouches are formed one under another. Moreover, once the soiled sponge is placed in the pouch, as is clearly illustrated in the patent, the top of the pouch remains substantially open, so that there is still considerable risk of air-borne contamination coming from the soiled sponges.
At the completion of the surgical procedure, a sponge count can be determined by visual inspection. However, during the surgical procedure, if the sponge count is carried out periodically as suggested by Darden, the sponges are lifted from the kick bucket to the pouches, so that blood loss may be determined more or less accurately by the weight of the total number of soiled sponges at any moment less their unused standard weight, assuming there has been no evaporation or drying of the blood from the sponges in the meantime; or by a visual integration or "eyeball" determination of the amount of blood in the pouches and in each of the sponges, together with what may be still in the kick bucket.
A similar apparatus is also taught by Dorton in his U.S. Pat. No. 4,234,086, issued Nov. 18, 1980, where the capability of smaller pouches to be made into larger pouches to accommodate larger sponges, by rupturing a connection between the front and rear panels thereof, is emphasized. However, the bag mouth is not covered, although the gaping thereof is limited by the provision of other, rupturable, connections between the front and rear panels.
Olsen, in U.S. Pat. No. 4,190,153, issued Feb. 26, 1980, teaches a tray having a plurality of formed containers with a thin sheet material cover, and an access opening for each container through a pair of crossed slits. However, there is no easy determination of blood loss, and there is excessive handling of the soiled sponges.
A recently issued U.S. Pat. No. 4,295,537 to McAvinn et al, dated Oct. 20, 1981, shows a device for measuring sponges by which a plurality of wetted sponges is held by a retaining device applied to a measuring device, and the total weight of liquid in the sponges is thereafter calculated by a determining device. Once again, excessive handling of the sponges is required, with a lack of visibility by the operating room personnel.
The present invention overcomes those difficulties, by providing means whereby blood loss may be more easily determined--especially according to a particular corollary to the invention whereby the kick bucket is replaced with a transparent and disposable container--and as well, provides means whereby excessive handling of the soiled sponges is precluded; and also whereby the soiled sponges may be substantially covered after placement for counting, thereby reducing the rate at which they dry--and thereby assuring greater accuracy of determination of blood loss--as well as reducing the risk of air-borne contamination. Indeed, the present invention provides a self-contained system whereby soiled surgical sponges may be counted, weighed and disposed of, and the system is particularly such that blood loss may be quite accurately determined at almost any moment, and which may be operated in a manner discussed hereafter.
However, by the present invention, it is possible that the weight of the soiled sponges may be taken repeatedly before, during and after the counting procedure, so that by such techniques an accurate blood loss weight determination may be made.
In its most simple embodiment, the present invention provides an apparatus for handling soiled sponges from surgical procedures, which comprises a strip of thermoplastic material having a plurality of pouches formed therein. Each pouch is formed having a front and rear wall, a top, a bottom and opposed sides, and the front and rear walls of each of said pouches are securely sealed one to the other at the bottom of each pouch and at least at one side of each pouch. Each pouch has an opening at its top side, between the front walls, with each opening being substantially horizontal. The pouches are arranged so as to be contiguous one to another at at least one adjoining pair of sides, or an adjoining top and bottom, or both.
We have discovered, rather unexpectedly, that the provision of an apparatus for handling soiled surgical sponges is such that the sponge count during and after the surgical procedure may be made easier, and that a determination of blood loss may be made not only by visual inspection but by weighing the soiled sponges, with a reasonable degree of accuracy. Moreover, we have noted that the present invention provides a substantially self-contained system for counting, weighing and disposal of surgical sponges, which is such that each of the sponges need only be handled once after it has been discarded by the surgeon, or nurse.
In so doing, we therefore contemplate that the present invention may provide a continuous strip of arrays of pouches, such that the apparatus thereby provided may be hung around the very edge of the kick bucket--or other apparatus which is contemplated to replace the bucket--so that a minimum of physical transference of the soiled sponges occurs. Moreover, blood loss may be more easily determined, either visually or by use of a weighing system, when it is included in the sponge handling system apparatus.
The present invention therefore also contemplates a substantially self-contained system for counting, weighing and disposing of soiled surgical sponges, whereby a receptacle--preferably adapted to and associated with a frame for holding the same--is provided, together with the counter strip and a weighing scale or other weighing system, whereby blood loss during the operation may be monitored and determined simply by maintaining a record of sponges used and the weight of the soiled sponges less their unused weight. Moreover, the accuracy of determination of blood loss is increased by weighing a number of sponges at once, thus reducing any inherent error in the weighing system, by reducing the error per sponge being weighed.
By this invention, a very inexpensive product is made available, where an accurate sponge count and/or a blood loss determination may be made at any time.
Thus, the present invention provides an inexpensive and self-contained sponge handling, counting, weighing, documenting and disposal system, for use in operating rooms, with a greater degree of asepsis.